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Completed

NCT Number: NCT01298843

Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

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Key information

Conditions

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site, Phoenix, Arizona, United States

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About this study

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet the following inclusion criteria:

  • Male or female children with ages from birth to younger than 12 years
  • Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
  • Sufficient intravascular access
  • Negative urine pregnancy test
  • Written informed consent from parent(s)and verbal informed assent from subject

Exclusion criteria

Subjects must NOT meet any of the following exclusion criteria:

  • History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
  • Past or current history of epilepsy or seizure disorder
  • Moderate or severe renal impairment
  • If female, currently pregnant or nursing
  • Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal
  • Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study
  • Use of probenecid within 3 days prior to dosing
  • Receipt of a blood transfusion during the 24-hour period before enrollment

Treatment and study plan

Ceftaroline fosamil

Drug

Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

Primary outcomes

  1. Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.

    Time frame: Up to 5 days

    This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2011
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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